A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial

Background The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients. Meth...
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Autor*in:	Kirkegaard, Hans [verfasserIn] Pedersen, Asger Roer Pettilä, Ville Hjort, Jakob Rasmussen, Bodil Steen de Haas, Inge Nielsen, Jørgen Feldbæk Ilkjær, Susanne Kaltoft, Anne Jeppesen, Anni Nørgaard Grejs, Anders Morten Duez, Christophe Henri Valdemar Larsen, Alf Inge Toome, Valdo Arus, Urmet Taccone, Fabio Silvio Storm, Christian Laitio, Timo Skrifvars, Markus B Søreide, Eldar

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2016

Schlagwörter:	Cardiac arrest Heart arrest Out-of-hospital Targeted temperature management Cerebral performance category Mortality Critical care Intensive care Randomised controlled trial

Anmerkung:	© The Author(s). 2016

Übergeordnetes Werk:	Enthalten in: Scandinavian journal of trauma, resuscitation and emergency medicine - London : BioMed Central, 2008, 24(2016), 1 vom: 28. Nov.
Übergeordnetes Werk:	volume:24 ; year:2016 ; number:1 ; day:28 ; month:11

Links:	Volltext

DOI / URN:	10.1186/s13049-016-0334-0

Katalog-ID:	SPR029686458

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520			\|a Background The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients. Methods TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%. Discussion We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. Trial registration ClinicalTrials.gov: NCT01689077, 17 September 2012
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700	1		\|a Laitio, Timo \|4 aut
700	1		\|a Skrifvars, Markus B \|4 aut
700	1		\|a Søreide, Eldar \|4 aut
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allfields	10.1186/s13049-016-0334-0 doi (DE-627)SPR029686458 (SPR)s13049-016-0334-0-e DE-627 ger DE-627 rakwb eng Kirkegaard, Hans verfasserin aut A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2016 Background The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients. Methods TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%. Discussion We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. Trial registration ClinicalTrials.gov: NCT01689077, 17 September 2012 Cardiac arrest (dpeaa)DE-He213 Heart arrest (dpeaa)DE-He213 Out-of-hospital (dpeaa)DE-He213 Targeted temperature management (dpeaa)DE-He213 Cerebral performance category (dpeaa)DE-He213 Mortality (dpeaa)DE-He213 Critical care (dpeaa)DE-He213 Intensive care (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Pedersen, Asger Roer aut Pettilä, Ville aut Hjort, Jakob aut Rasmussen, Bodil Steen aut de Haas, Inge aut Nielsen, Jørgen Feldbæk aut Ilkjær, Susanne aut Kaltoft, Anne aut Jeppesen, Anni Nørgaard aut Grejs, Anders Morten aut Duez, Christophe Henri Valdemar aut Larsen, Alf Inge aut Toome, Valdo aut Arus, Urmet aut Taccone, Fabio Silvio aut Storm, Christian aut Laitio, Timo aut Skrifvars, Markus B aut Søreide, Eldar aut Enthalten in Scandinavian journal of trauma, resuscitation and emergency medicine London : BioMed Central, 2008 24(2016), 1 vom: 28. Nov. (DE-627)582019125 (DE-600)2455990-8 1757-7241 nnns volume:24 year:2016 number:1 day:28 month:11 https://dx.doi.org/10.1186/s13049-016-0334-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2016 1 28 11
spelling	10.1186/s13049-016-0334-0 doi (DE-627)SPR029686458 (SPR)s13049-016-0334-0-e DE-627 ger DE-627 rakwb eng Kirkegaard, Hans verfasserin aut A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2016 Background The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients. Methods TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%. Discussion We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. Trial registration ClinicalTrials.gov: NCT01689077, 17 September 2012 Cardiac arrest (dpeaa)DE-He213 Heart arrest (dpeaa)DE-He213 Out-of-hospital (dpeaa)DE-He213 Targeted temperature management (dpeaa)DE-He213 Cerebral performance category (dpeaa)DE-He213 Mortality (dpeaa)DE-He213 Critical care (dpeaa)DE-He213 Intensive care (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Pedersen, Asger Roer aut Pettilä, Ville aut Hjort, Jakob aut Rasmussen, Bodil Steen aut de Haas, Inge aut Nielsen, Jørgen Feldbæk aut Ilkjær, Susanne aut Kaltoft, Anne aut Jeppesen, Anni Nørgaard aut Grejs, Anders Morten aut Duez, Christophe Henri Valdemar aut Larsen, Alf Inge aut Toome, Valdo aut Arus, Urmet aut Taccone, Fabio Silvio aut Storm, Christian aut Laitio, Timo aut Skrifvars, Markus B aut Søreide, Eldar aut Enthalten in Scandinavian journal of trauma, resuscitation and emergency medicine London : BioMed Central, 2008 24(2016), 1 vom: 28. Nov. (DE-627)582019125 (DE-600)2455990-8 1757-7241 nnns volume:24 year:2016 number:1 day:28 month:11 https://dx.doi.org/10.1186/s13049-016-0334-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2016 1 28 11
allfields_unstemmed	10.1186/s13049-016-0334-0 doi (DE-627)SPR029686458 (SPR)s13049-016-0334-0-e DE-627 ger DE-627 rakwb eng Kirkegaard, Hans verfasserin aut A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2016 Background The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients. Methods TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%. Discussion We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. Trial registration ClinicalTrials.gov: NCT01689077, 17 September 2012 Cardiac arrest (dpeaa)DE-He213 Heart arrest (dpeaa)DE-He213 Out-of-hospital (dpeaa)DE-He213 Targeted temperature management (dpeaa)DE-He213 Cerebral performance category (dpeaa)DE-He213 Mortality (dpeaa)DE-He213 Critical care (dpeaa)DE-He213 Intensive care (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Pedersen, Asger Roer aut Pettilä, Ville aut Hjort, Jakob aut Rasmussen, Bodil Steen aut de Haas, Inge aut Nielsen, Jørgen Feldbæk aut Ilkjær, Susanne aut Kaltoft, Anne aut Jeppesen, Anni Nørgaard aut Grejs, Anders Morten aut Duez, Christophe Henri Valdemar aut Larsen, Alf Inge aut Toome, Valdo aut Arus, Urmet aut Taccone, Fabio Silvio aut Storm, Christian aut Laitio, Timo aut Skrifvars, Markus B aut Søreide, Eldar aut Enthalten in Scandinavian journal of trauma, resuscitation and emergency medicine London : BioMed Central, 2008 24(2016), 1 vom: 28. Nov. (DE-627)582019125 (DE-600)2455990-8 1757-7241 nnns volume:24 year:2016 number:1 day:28 month:11 https://dx.doi.org/10.1186/s13049-016-0334-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2016 1 28 11
allfieldsGer	10.1186/s13049-016-0334-0 doi (DE-627)SPR029686458 (SPR)s13049-016-0334-0-e DE-627 ger DE-627 rakwb eng Kirkegaard, Hans verfasserin aut A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2016 Background The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients. Methods TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%. Discussion We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. Trial registration ClinicalTrials.gov: NCT01689077, 17 September 2012 Cardiac arrest (dpeaa)DE-He213 Heart arrest (dpeaa)DE-He213 Out-of-hospital (dpeaa)DE-He213 Targeted temperature management (dpeaa)DE-He213 Cerebral performance category (dpeaa)DE-He213 Mortality (dpeaa)DE-He213 Critical care (dpeaa)DE-He213 Intensive care (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Pedersen, Asger Roer aut Pettilä, Ville aut Hjort, Jakob aut Rasmussen, Bodil Steen aut de Haas, Inge aut Nielsen, Jørgen Feldbæk aut Ilkjær, Susanne aut Kaltoft, Anne aut Jeppesen, Anni Nørgaard aut Grejs, Anders Morten aut Duez, Christophe Henri Valdemar aut Larsen, Alf Inge aut Toome, Valdo aut Arus, Urmet aut Taccone, Fabio Silvio aut Storm, Christian aut Laitio, Timo aut Skrifvars, Markus B aut Søreide, Eldar aut Enthalten in Scandinavian journal of trauma, resuscitation and emergency medicine London : BioMed Central, 2008 24(2016), 1 vom: 28. Nov. (DE-627)582019125 (DE-600)2455990-8 1757-7241 nnns volume:24 year:2016 number:1 day:28 month:11 https://dx.doi.org/10.1186/s13049-016-0334-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2016 1 28 11
allfieldsSound	10.1186/s13049-016-0334-0 doi (DE-627)SPR029686458 (SPR)s13049-016-0334-0-e DE-627 ger DE-627 rakwb eng Kirkegaard, Hans verfasserin aut A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2016 Background The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients. Methods TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%. Discussion We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. Trial registration ClinicalTrials.gov: NCT01689077, 17 September 2012 Cardiac arrest (dpeaa)DE-He213 Heart arrest (dpeaa)DE-He213 Out-of-hospital (dpeaa)DE-He213 Targeted temperature management (dpeaa)DE-He213 Cerebral performance category (dpeaa)DE-He213 Mortality (dpeaa)DE-He213 Critical care (dpeaa)DE-He213 Intensive care (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Pedersen, Asger Roer aut Pettilä, Ville aut Hjort, Jakob aut Rasmussen, Bodil Steen aut de Haas, Inge aut Nielsen, Jørgen Feldbæk aut Ilkjær, Susanne aut Kaltoft, Anne aut Jeppesen, Anni Nørgaard aut Grejs, Anders Morten aut Duez, Christophe Henri Valdemar aut Larsen, Alf Inge aut Toome, Valdo aut Arus, Urmet aut Taccone, Fabio Silvio aut Storm, Christian aut Laitio, Timo aut Skrifvars, Markus B aut Søreide, Eldar aut Enthalten in Scandinavian journal of trauma, resuscitation and emergency medicine London : BioMed Central, 2008 24(2016), 1 vom: 28. Nov. (DE-627)582019125 (DE-600)2455990-8 1757-7241 nnns volume:24 year:2016 number:1 day:28 month:11 https://dx.doi.org/10.1186/s13049-016-0334-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2016 1 28 11
language	English
source	Enthalten in Scandinavian journal of trauma, resuscitation and emergency medicine 24(2016), 1 vom: 28. Nov. volume:24 year:2016 number:1 day:28 month:11
sourceStr	Enthalten in Scandinavian journal of trauma, resuscitation and emergency medicine 24(2016), 1 vom: 28. Nov. volume:24 year:2016 number:1 day:28 month:11
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Cardiac arrest Heart arrest Out-of-hospital Targeted temperature management Cerebral performance category Mortality Critical care Intensive care Randomised controlled trial
isfreeaccess_bool	true
container_title	Scandinavian journal of trauma, resuscitation and emergency medicine
authorswithroles_txt_mv	Kirkegaard, Hans @@aut@@ Pedersen, Asger Roer @@aut@@ Pettilä, Ville @@aut@@ Hjort, Jakob @@aut@@ Rasmussen, Bodil Steen @@aut@@ de Haas, Inge @@aut@@ Nielsen, Jørgen Feldbæk @@aut@@ Ilkjær, Susanne @@aut@@ Kaltoft, Anne @@aut@@ Jeppesen, Anni Nørgaard @@aut@@ Grejs, Anders Morten @@aut@@ Duez, Christophe Henri Valdemar @@aut@@ Larsen, Alf Inge @@aut@@ Toome, Valdo @@aut@@ Arus, Urmet @@aut@@ Taccone, Fabio Silvio @@aut@@ Storm, Christian @@aut@@ Laitio, Timo @@aut@@ Skrifvars, Markus B @@aut@@ Søreide, Eldar @@aut@@
publishDateDaySort_date	2016-11-28T00:00:00Z
hierarchy_top_id	582019125
id	SPR029686458
language_de	englisch
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author	Kirkegaard, Hans
spellingShingle	Kirkegaard, Hans misc Cardiac arrest misc Heart arrest misc Out-of-hospital misc Targeted temperature management misc Cerebral performance category misc Mortality misc Critical care misc Intensive care misc Randomised controlled trial A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial
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topic_title	A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial Cardiac arrest (dpeaa)DE-He213 Heart arrest (dpeaa)DE-He213 Out-of-hospital (dpeaa)DE-He213 Targeted temperature management (dpeaa)DE-He213 Cerebral performance category (dpeaa)DE-He213 Mortality (dpeaa)DE-He213 Critical care (dpeaa)DE-He213 Intensive care (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213
topic	misc Cardiac arrest misc Heart arrest misc Out-of-hospital misc Targeted temperature management misc Cerebral performance category misc Mortality misc Critical care misc Intensive care misc Randomised controlled trial
topic_unstemmed	misc Cardiac arrest misc Heart arrest misc Out-of-hospital misc Targeted temperature management misc Cerebral performance category misc Mortality misc Critical care misc Intensive care misc Randomised controlled trial
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title	A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial
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title_full	A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial
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author_browse	Kirkegaard, Hans Pedersen, Asger Roer Pettilä, Ville Hjort, Jakob Rasmussen, Bodil Steen de Haas, Inge Nielsen, Jørgen Feldbæk Ilkjær, Susanne Kaltoft, Anne Jeppesen, Anni Nørgaard Grejs, Anders Morten Duez, Christophe Henri Valdemar Larsen, Alf Inge Toome, Valdo Arus, Urmet Taccone, Fabio Silvio Storm, Christian Laitio, Timo Skrifvars, Markus B Søreide, Eldar
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title_sort	statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (tth48) clinical trial
title_auth	A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial
abstract	Background The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients. Methods TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%. Discussion We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. Trial registration ClinicalTrials.gov: NCT01689077, 17 September 2012 © The Author(s). 2016
abstractGer	Background The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients. Methods TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%. Discussion We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. Trial registration ClinicalTrials.gov: NCT01689077, 17 September 2012 © The Author(s). 2016
abstract_unstemmed	Background The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients. Methods TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%. Discussion We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. Trial registration ClinicalTrials.gov: NCT01689077, 17 September 2012 © The Author(s). 2016
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title_short	A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial
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A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial

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